Method for suture lacing

ABSTRACT

A method for suture lacing includes providing a suture with a needle attached thereto, inserting the needle and suture into an organ through a passageway, throwing a single stitch through a first tissue member, throwing a single stitch through an opposed and spaced apart second tissue member, repeating the preceding step at least once, bringing the first and second tissue members in contact by tensioning the suture, whereby suture drag is minimized during the tensioning and even tissue compression substantially achieved, and securing the suture.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/150,481, entitled “ENDOSCOPIC SUTURING DEVICE”, filed Jun.13, 2005, which is currently pending.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a method for suturing lacing.

2. Description of the Prior Art

Endoscopic procedures have been rapidly developing over the past decade.These procedures often allow for the performance of surgical procedureswith minimal trauma when compared to prior techniques requiring a largeexternal opening to expose the internal organ or tissue requiringrepair.

In addition to the many areas in which endoscopic procedures have founduse, endoscopic procedures have been developed for surgical proceduresaddressing morbid obesity. Morbid obesity is a serious medicalcondition. In fact, morbid obesity has become highly pervasive in theUnited States, as well as other countries, and the trend appears to beheading in a negative direction. Complications associated with morbidobesity include hypertension, diabetes, coronary artery disease, stroke,congestive heart failure, multiple orthopedic problems and pulmonaryinsufficiency with markedly decreased life expectancy. With this inmind, and as those skilled in the art will certainly appreciate, themonetary and physical costs associated with morbid obesity aresubstantial. In fact, it is estimated the costs relating to obesity arein excess of 100 billion dollars in the United States alone.

A variety of surgical procedures have been developed to treat obesity.One procedure is Roux-en-Y gastric bypass (RYGB). This operation ishighly complex and is commonly utilized to treat people exhibitingmorbid obesity. Around 35,000 procedures are performed annually in theUnited States alone. Other forms of bariatric surgery include Fobipouch, bilio-pancreatic diversion, and gastroplasty or “stomachstapling”. In addition, implantable devices are known which limit thepassage of food through the stomach and affect satiety.

RYGB involves movement of the jejunum to a high position using aRoux-en-Y loop. The stomach is completely divided into two unequalportions (a smaller upper portion and a larger lower gastric pouch)using an automatic stapling device. The upper pouch typically measuresless than about 1 ounce (or 20 cc), while the larger lower pouch remainsgenerally intact and continues to secret stomach juices flowing throughthe intestinal track.

A segment of the small intestine is then brought from the lower abdomenand joined with the upper pouch to form an anastomosis created through ahalf-inch opening, also called the stoma. This segment of the smallintestine is called the “Roux loop” Roux limb and carries the food fromthe upper pouch to the remainder of the intestines, where the food isdigested. The remaining lower pouch and the attached segment of duodenumare then reconnected to form another anastomotic connection to the Rouxloop limb at a location approximately 50 to 150 cm from the stoma,typically using a stapling instrument. It is at this connection that thedigestive juices from the bypass stomach, pancreas, and liver, enter thejejunum and ileum to aide in the digestion of food. Due to the smallsize of the upper pouch, patients are forced to eat at a slower rate andare satiated much more quickly. This results in a reduction in caloricintake.

As those skilled in the art will certainly appreciate, the conventionalRYGB procedure requires a great deal of operative time. Because of thedegree of invasiveness, post-operative recovery time can be quitelengthy and painful. In view of the highly invasive nature relating tothe current RYGB procedure, other less invasive procedures have beendeveloped. With this mind other procedures for reducing the size of thestomach have been developed. The most common form of gastric reductionsurgery involves the application of vertical staples along the stomachto create an appropriate pouch. This procedure is commonly performedlaparoscopically and as such requires substantial preoperative,operative, postoperative resources.

As endoscopic devices and procedures have developed, surgeons have begunto employ endoscopic techniques to gastric procedures such as thosediscussed above in an effort to minimize trauma and reduce the timerequired for procedures and recovery. With the foregoing in mind,procedures and apparatuses that allow for the performance of gastricreduction surgery in a time efficient and patient friendly manner areneeded.

One area that has not been adequately addressed is the need for theapplication of sutures as these gastric, and other endoscopic,procedures are being performed. The present invention provides anendoscopic suturing device adapted for the continuous application ofsutures.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide a methodfor suture lacing including providing a suture with a needle attachedthereto, inserting the needle and suture into an organ through apassageway, throwing a single stitch through a first tissue member,throwing a single stitch through an opposed and spaced apart secondtissue member, repeating the preceding step at least once, bringing thefirst and second tissue members in contact by tensioning the suture,whereby suture drag is minimized during the tensioning and even tissuecompression substantially achieved, and securing the suture.

It is also an object of the present invention to provide a methodwherein the suture includes first and second leads, and the step ofsecuring includes knotting the first and second leads of the suture.

It is another object of the present invention to provide a methodwherein the suture includes first and second leads and the step ofsecuring includes anchoring at least one of the first and second leadsof the suture to tissue.

It is a further object of the present invention to provide a methodwherein the step of securing includes anchoring both the first andsecond leads of the suture to tissue.

It is also another object of the present invention to provide a methodwherein the step of inserting includes insertion through a naturalorifice of a patient.

It is also a further object of the present invention to provide a methodwherein the step of inserting includes insertion through an orifice fromapproximately 3 mm to approximately 24 mm in diameter.

It is still another object of the present invention to provide a methodwherein the step of inserting includes insertion through a trocar.

It is yet a further object of the present invention to provide a methodwherein the step of inserting includes insertion through an orifice fromapproximately 3 mm to approximately 18 mm in diameter.

It is also an object of the present invention to provide a methodincluding a step of reversing the direction of a final suture throw.

It is another object of the present invention to provide a methodwherein the step of reversing includes positioning a reversing pinbetween the suture and either the first tissue member or the secondtissue member.

Other objects and advantages of the present invention will becomeapparent from the following detailed description when viewed inconjunction with the accompanying drawings, which set forth certainembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the present invention with the vacuumchamber secured thereto.

FIG. 2 is a perspective view of the present invention without the vacuumchamber.

FIGS. 3 through 10 are cut away views demonstrating operation of thepresent invention.

FIG. 11 is a perspective view showing a suturing body with a vacuumchamber in accordance with a preferred embodiment secured thereto.

FIG. 12 shows an alternate vacuum chamber secured to the suturing body.

FIGS. 13 and 14 are top views of yet another vacuum chamber secured tothe suturing body, wherein FIG. 13 shows the vacuum chamber in itsexpanded configuration and FIG. 14 shows the vacuum chamber in its lowprofile configuration.

FIG. 15 is a cut away view of the suturing body showing a smoothfriction camming member.

FIG. 16 is an alternate embodiment of the suturing body showing atoothed friction camming member.

FIG. 17 is a cut away view of yet another embodiment of the suturingbody with a gear driven friction camming member.

FIGS. 18 and 19 are cut away views of the suturing body showingalternate back-up mechanisms which may be utilized in accordance withthe present invention.

FIGS. 20, 21 and 22 are various views of a suturing body including a campin set mechanism utilized in selectively opening the suture housing.

FIGS. 23 and 24 are bottom views of a suturing body showing a tear stripmechanism utilized in selectively opening the suture housing.

FIGS. 25 and 26 are bottom views of a suturing body showing yet anothermechanism utilized in selectively opening the suture housing.

FIGS. 27 and 28 are bottom views of a suturing body showing a spreaderplate mechanism utilized in selectively opening the suture housing.

FIGS. 29, 30 and 31 are various views of a suturing body showing analternate mechanism for selectively opening the suture housing.

FIG. 32 is a cut away view of the suturing body showing a needleposition indicating mechanism.

FIG. 33 is a cut away view of the suturing body showing an alternateneedle position indicating mechanism.

FIG. 34 is perspective view of a suturing body employing an alternateneedle position indicating mechanism wherein an indicator pin is shownin its hidden position.

FIG. 35 is a cross sectional view of the needle position indicatingmechanism shown in FIG. 34 with the indicator pin shown in its hiddenposition.

FIG. 36 is perspective view of the suturing body shown in FIG. 34 withthe indicator pin in its exposed position.

FIG. 37 is a cross sectional view of the needle position indicatingmechanism shown in FIG. 36 with the indicator pin in its exposedposition.

FIG. 38 is a detailed side, cut away view showing a colored needleutilized in needle position identification.

FIG. 39 is a perspective view showing a visual indicator linked tovarious sensors for identifying needle position.

FIGS. 40, 41, 41 a, 42, 42 a and 43 are various views showing anattachment mechanism for securing the present suturing apparatus to anendoscope.

FIGS. 44, 45 and 46 show a guidewire introducer mechanism for use inconjunction with the present suturing apparatus.

FIGS. 47, 48, 49, 50 and 51 disclose a detachable handle mechanism forutilization in conjunction with the present suturing apparatus.

FIGS. 52 through 61 disclose various techniques for suture lacing inaccordance with the present invention.

FIG. 62 is a perspective view of a knotting element in accordance withthe present invention.

FIG. 63 is a perspective view showing fusing of knotted sutures.

FIGS. 64, 65, 66, 67 and 68 are perspective views showing varioussuction vacuum assist mechanisms in accordance with the presentinvention.

FIG. 69 shows a suturing technique utilizing an adhesive/sealant.

FIGS. 70, 71 and 72 show a perforated suture utilized in supplyingadhesive/sealant to a suture line.

FIGS. 73 through 82 disclose a procedure whereby a stomach pouch iscreated through the application of an adhesive/sealant.

FIGS. 83 and 84 are perspective views of a suturing apparatusincorporating an imaging device within the suturing body.

FIG. 85 is a cut away view of the suturing body showing a cartridgemechanism for utilization therewith.

FIG. 86 is a cut away view of the suturing body showing a cartridgemechanism having a smaller needle.

FIGS. 87 and 88 are side views showing a needle loading mechanism inaccordance with the present invention.

FIGS. 89, 90 and 91 disclose screw-based mechanisms for adjusting thesize of the vacuum chamber and central opening.

FIG. 92 is a cut away view showing a wire-based mechanism for adjustingthe effective depth of the vacuum chamber and central opening.

FIG. 93 is a top view showing a cinching line utilized in adjusting theeffective size of the vacuum chamber and central opening.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The detailed embodiments of the present invention are disclosed herein.It should be understood, however, that the disclosed embodiments aremerely exemplary of the invention, which may be embodied in variousforms. Therefore, the details disclosed herein are not to be interpretedas limiting, but merely as the basis for the claims and as a basis forteaching one skilled in the art how to make and/or use the invention.

With reference to FIGS. 1 to 10, an endoscopic suturing apparatus 10 forthe continuous application of a suture 12 is disclosed. The term“suture” as used throughout the body of the present application isintended to refer to a variety of flexible securing filaments whetherthey be made of natural filament, synthetic or polymeric filaments, ormetallic wire filaments.

Although the present suturing apparatus is particularly adapted for usein performing endoscopic gastric reduction procedures, those skilled inthe art will certainly appreciate the apparatus may be used for a widevariety of applications without departing from the spirit of the presentinvention. More particularly, the present suturing apparatus is shapedand dimensioned for insertion through a natural orifice of a patient,for example, transorally, and is, therefore, shaped and dimensioned forinsertion through an orifice from approximately 3 mm to approximately 24mm in diameter. Although the present suturing apparatus is particularlyadapted for insertion through a patient's natural orifice, the presentsuturing apparatus may be shaped and dimensioned for laparoscopicinsertion through a trocar, and is, therefore, shaped and dimensionedfor insertion through an orifice from approximately 3 mm toapproximately 18 mm in diameter.

The suturing apparatus 10 includes a suturing body 14 shaped anddimensioned for attachment to the distal end 16 of a commerciallyavailable endoscope, or other supporting structure, 18 in a mannerpermitting actuation thereof and the creation of a vacuum. With this inmind, the suturing body 14 is secured to the endoscope 18 using knownattachment structures appreciated by those skilled in the art.

The suturing body 14 is composed of a first housing member 20 and asecond housing member 22 secured together to create a suture housing 24in which the functional components of the present apparatus 10 arehoused for movement in accordance with the present invention. The suturehousing 24 includes an inner first track 26 in which a needle 28 ispositioned for movement about a predetermined continuous circular pathunder the control of a drive assembly 30.

Although the present suturing apparatus is disclosed in accordance witha preferred embodiment as providing for the translation of the needleabout a continuous circular path, it is contemplated many of theconcepts underlying the present invention may be applied in systemswherein the needle is merely moved along an arcuate path, and notnecessarily along a continuous circular path.

The drive assembly 30 is supported within second and third tracks 32, 34positioned about the inner first track 26. The drive assembly 30 appliesaxial motion to cause movement of the needle 28 about its continuouscircular path. The drive assembly 30 is generally composed of a frictionplate 36 statically mounted along the second track 32 and a frictioncamming member 38 that moves along the second track 32 while a pin 40moves along the outer third track 34. A drive cable 42 is coupled to thepin 40 for controlling actuation thereof in the manner described belowin greater detail. The drive cable 42 is actuated for movement of thedrive assembly 30 by a handle (for example, as shown in FIGS. 47 to 51).Although a preferred handle is disclosed below, it is contemplated avariety of handle structures may be utilized in the actuation of thedrive cable without departing from the spirit of the present invention.

For reasons that will become apparent based upon the operation of thepresent suture apparatus 10 as described below in greater detail, thesuturing body 14 is substantially C-shaped with a central opening 44 inwhich tissue is positioned during suturing. The C-shape of the suturingbody 14 allows the needle 28 to move about a circular path duringoperation thereof and pass through tissue positioned with the centralopening.

Referring to FIGS. 1 and 2, and in accordance with a preferredembodiment, the present endoscopic suturing apparatus 10 is attached toa commercially available endoscope 18 by way of a clamp 17. As brieflymentioned above, and as discussed below in greater detail, the suturingapparatus 10 may be secured to the endoscope 18 in a variety of wayswithout departing from the spirit of the present invention. The suturingapparatus 10 is oriented in a way that allows the user to maintainvisibility of the needle 28 and operative field, as well as create asmall cross section to aid in transoral insertion (when the suturingapparatus 10 is used in gastric surgical procedures).

A vacuum chamber 46 surrounds and/or otherwise contains the suturingbody 14 of the present suture apparatus 10. This defines a cavity 48 inwhich the suturing body 14 sits. The vacuum chamber 46 is coupled to thevacuum line 50, which is coupled in tandem to the endoscope 18, but notin the working channel of the endoscope 18, such that a vacuum iscreated within the cavity 48 defined by the vacuum chamber 46, as wellas the central opening 44 of the suturing body 14. In this way, theapplication of the vacuum draws adjacent tissue into the central opening44 of the suturing body 14.

As briefly mentioned above, the present suturing apparatus 10 isprovided with a vacuum chamber 46 designed to enhance one's ability todraw tissue into a position for suturing. The vacuum chamber 46 isshaped and dimensioned to facilitate pulling the tissue wall into thevacuum chamber 46, and particularly, the central opening 44 of thesuturing body 14, under the control of the applied vacuum. Once drawnwithin the vacuum chamber 46 and the central opening 44, the tissue isheld therein as the needle 28 is passed therethrough while the suturingbody 14 throws stitches. The required vacuum chamber 46 size is basedupon the thickness of the tissue being sutured. The vacuum necessary topull the desired tissue thickness is proportionate to both the thicknessof the tissue and the size of the vacuum chamber 46.

As a result, the present vacuum chamber 46 attempts to increase the sizethereof to minimize the required vacuum for accomplishing the task,without making the vacuum chamber 46 too large for passage into thestomach. The ability of the present vacuum chamber 46 to achieve desiredsuction with vacuum pressure provided at a hospital or other medicalfacility is especially important considering the magnitude of vacuumsources available at different hospitals, as well as within differentsurgical suites, varies greatly.

With this in mind, and in accordance with preferred embodiments of thepresent invention as shown in FIGS. 11 and 12, (where similar referencenumerals are used for similar parts) the vacuum chamber 146 isconstructed from a resilient elastomer. It is cup-like in itsconfiguration and generally includes an inner wall 170 and an outer wall172. The inner wall 170 of the vacuum chamber 146 is preferably providedwith projections, for example, ribs and/or hooks, 174 (as shown in FIG.12) to further improve the ability of the vacuum chamber 146 to retaintissue drawn thereon under suction. These projections 174 providegrabbing surfaces for the tissue to be pinned against when the vacuum isapplied to the vacuum chamber 146. The projections 174 also increase theholding power of the vacuum thereby minimizing the amount of vacuumneeded.

In accordance with a preferred embodiment, the vacuum chamber 146 iscomposed of first and second vacuum chamber members 176, 178 secured toopposite sides of the suturing body 114 in a manner containing, orotherwise surrounding, the functional components of the suturing body114. The first and second chamber members 176, 178 are mirror images ofeach other and define a space surrounding the suturing body 114 for thecreation of a vacuum. In accordance with a preferred embodiment, thefirst and second vacuum chamber members 176, 178 define a cup-like spacein which the suturing body 114 is positioned.

Each of the first and second vacuum chamber members 176, 178 includes asemicircular upper edge 184 and a concave lower portion 186. As such,when the first and second vacuum chamber members 176, 178 are securedalong opposite sides of the suturing body 114, the cup-like space isdefined about the suturing body 114. The cup-like space provides aconfined space in which the suction provided by the vacuum isconstrained so as to securely and efficiently draw tissue into thecentral opening 144 of the suturing body 114.

The first and second vacuum chamber members 176, 178 of the vacuumchamber 146 are manufactured from an elastomer, for example, urethane,adiprene or santoprene. The vacuum chamber 146 is designed to permitexpansion and contraction thereof. The provision of an expandable vacuumchamber 146 maximizes chamber size to increase tissue inclusion duringvacuum application, while permitting reduced vacuum chamber 146 sizeduring insertion of the suturing apparatus 110. More particularly, theability of the vacuum chamber 146 to expand and contract facilitatestrans-oral passage of the suturing apparatus 110 while similarlyoptimizing vacuum chamber 146 size during tissue suction.

As those skilled in the art will appreciate, the need for trans-oralpassage of the suturing apparatus 110 defines an ultimate limit on thedimensions of the suturing apparatus 110 and, therefore, the vacuumchamber 146 that can be introduced to capture tissue in accordance withthe present invention. The larger the vacuum chamber 146, the larger the“bite” of tissue that can be captured in one throw of the suturingapparatus 110. With this in mind, and as discussed above, the vacuumchamber 146 is made out of an elastomer allowing it to be collapsedduring insertion and then “spring” back to its original shape after itis fully inserted.

In accordance with an alternate embodiment, and with reference to FIGS.13 and 14, expansion of the vacuum chamber 246 is further facilitated bythe provision of living hinges 280 at predefined bending points of thecavity 248 defined by the vacuum chamber 246. This allows the vacuumchamber 246 to be constructed of a wider variety of materials, includingnon-elastic plastics, since the living hinges 280 permit the more rigidstructures to “fold” rather than elastically bend. More particular, andwith reference to the prior embodiment, the vacuum chamber 246 iscomposed of a first vacuum chamber member 276 and a second vacuumchamber member 278. The first and second vacuum chamber members 276, 278are mirror images of each other, and each includes a semi-circular uppersection 284 and a concave lower section 286. As a result, the first andsecond vacuum chamber members 276, 278 are coupled to opposite sides ofthe suturing body 214 to form the present vacuum chamber 246, which cansimilarly include the ribs and/or hooks discussed above with regard tothe prior embodiment.

In accordance with a preferred embodiment, the first and second vacuumchamber members 276, 278 are constructed of a semi-rigid material and,therefore, respectively include living hinges 280 permitting expansionand contraction thereof. The living hinges 280 are positioned atpredefined bending points of the first and second vacuum chamber members276, 278 in a manner optimizing folding thereof. The living hinges 280permits controlled expansion and contraction of the vacuum chamber 246as the first and second vacuum chamber members 276, 278 are movedrelative to each other in accordance with the present invention. One is,therefore, able to pass a vacuum chamber 246 that is ultimately, whenused, larger than the trans-oral space through which it is passed.

Those skilled in the art will appreciate it is would be desirable tomake a vacuum chamber and central opening adapted to accommodate anytype of tissue, any thickness of tissue and be able to allow the user toadjust the bite size (that is, the extent of tissue through which thesuture is thrown). To this end, various embodiments for the adjustmentof the effective vacuum chamber and central opening size have beendeveloped and are disclosed herein. These embodiments also allow forlongitudinal and lateral adjustment of the vacuum chamber, as well asdepth adjustment of the central opening and vacuum chamber, to allow foruse with different tissue thicknesses, different tissue types andvariable tissue bites per suture throw. In this way the surgeon isallowed to readily adjust the effective vacuum chamber/central openingdepth, width and/or length to allow for adjustment of the depth of thetissue bite, which controls the depth of the needle path through thetissue (i.e., full thickness or partial thickness). The ability foradjustment also allows the same suturing apparatus to be used formultiple tissue types and thicknesses. While limiting the maximum amountof tissue that may be drawn into the vacuum chamber and central opening,the present techniques may also be applied to ensure that apredetermined and controlled amount of tissue is drawn into the vacuumchamber and the central opening.

In accordance with a preferred embodiment, and with reference to FIGS.89, 90 and 91, adjustment is accomplished by the provision of adjustingscrews 3970 in the base 3972 of the vacuum chamber 3946. The screws 3970respectively allow for longitudinal or lateral adjustment of the vacuumchamber 3946 by adjusting a screw 3970 in the base 3972 of the vacuumchamber 3946 that expands or contracts the vacuum chamber 3946 in adesired direction.

In accordance with another embodiment, and with reference to FIG. 92 awire 4070 is used to raise the effective base of the vacuum chamber 4046and the central opening 4044 controlling the effective depth of thevacuum chamber 4046 and the central opening 4044. This wire 4070 is abuckled spacing wire that can be further buckled or allowed tostraighten, effectively reducing the depth to which the tissue can enterthe cavity defined by the central opening 4044 and the vacuum chamber4046. The straighter the spring wire 4070 is allowed to be, the higherthe effective bottom of the cavity is set. The spring wire 4070 therebyprevents deep entrance of tissue (that is, entrance beyond the barriercreated by the spring wire 4070) into the central opening 4044. Theslack in the wire 4070 is controlled via a screw member 4072 foundwithin the suturing body 4014 for actuation of the wire 4070.

Referring to FIG. 93, and in accordance with another embodiment, acinching cable 4170 is used to adjust the effective length of the vacuumchamber 4148. In particular, a cinching cable 4170 is threaded about theouter perimeter of the vacuum chamber 4146, with the free ends 4172,4174 thereof exiting at the proximal end of the vacuum chamber 4146. Assuch, the free ends 4172, 4174 may be tensioned to shorten the vacuumchamber 4146 length, and similarly released when it is desired toincrease the length of the vacuum chamber 4146 by allowing the wallsthereof to expand to their unbiased position.

As mentioned above, the housing 24 contains the needle 28 used in theapplication of a suture 12 to the tissue drawn within the centralopening 44. The suture 12 is secured to the proximal end, that is, theblunt end, of the needle 28 and is drawn through the tissue as theneedle 28 is actuated in accordance with the present invention asdescribed herein. In accordance with a preferred embodiment, the needle28 is curved to rotate about a predetermined continuous circular pathand extends along an arc of 240 degrees creating an opening of 120degrees. However, those skilled in the art will appreciate the openingmay be varied; for example, it has been contemplated to use a needleoffering an opening of 140 degrees.

The needle 28 includes an interior surface 52 along the inner surface ofthe arc defined by the needle 28 and an exterior surface 54 along theouter surface of the arc defined by the needle 28. A series of notches56 are cut into the exterior surface 54 of the needle 28. As will beappreciated based upon the following description, the notches 56 areshaped and dimensioned for use by the drive assembly 30 in grabbing,driving and releasing the needle 28. Although notches along the exteriorsurface of the needle are disclosed for use in accordance with apreferred embodiment of the present invention, it is contemplated theneedle may be formed without notches such that the drive assembly merelygrips the substantially smooth exterior surface of the needle to driveit forward.

Operation of the drive assembly 30 and movement of the needle 28 isdescribed with reference to FIGS. 3 to 10, wherein one half of thehousing 24 is removed exposing internal components of the present sutureapparatus 10. The drive cable 42 (shown in FIG. 3) is rigidly attachedto the pin 40. As is described below in greater detail, the drive cable42, pin 40 and friction camming member 38 are extended and retracted toengage and disengage the needle 28 for movement thereof about itscircular path. The drive cable 42 is flexible enough to curve in thehousing 24 and flex along with the endoscope 18, but is rigid enough tobe compressed to drive the friction camming member 38 into its initialdrive stage (see FIG. 4).

The friction camming member 38 is composed of an arcuate engagementmember 58 and a camming member 60 working in conjunction with the pin 40to control the position of the engagement member 58 for selectiveengagement with the needle 28. The engagement member 58 is constructedwith internal notches 62 shaped and dimensioned for engaging the needle28 to drive it in a clockwise direction, but permit free movementthereof as the friction camming member 38, that is, both the engagementmember 58 and the camming member 60, is moved in a counter-clockwisedirection toward the initial drive stage.

The engagement member 58 of the friction camming member 38 is designedto translate in the housing 24 both radially towards and away from theneedle 28, as well as translate arcuately clockwise and counterclockwiseabout the arc defined by the housing 24. This is achieved through thecamming action offered by the interaction between the camming member 60,the pin 40 and the engagement member 58. The camming member 60 isrigidly coupled to the engagement member 58 such that the engagementmember 58 is moved into and out of engagement with the needle 28 as theradial position of the camming member 60 is altered based upon itsinteraction with the pin 40. As discussed below in accordance with analternate embodiment, it is contemplated that a spring element may beemployed to force the friction camming member 38 against the needle 28.

More particularly, as the drive cable 42 is compressed (that is, thedrive cable 42 is pushed distally away from the operation of thesuturing apparatus 10) to move the friction camming member 38 in acounter-clockwise direction, the pin 40 slides within a slot 64 formedin the camming member 60 forcing the engagement member 58 and cammingmember 60 to move counterclockwise as well as outwardly from the needle28. The friction plate 36 aids in forcing the engagement member 58outwardly from the needle 28 as the friction camming member 38 is movedin this counter-clockwise direction.

With the friction camming member 38 in its initial drive position asshown in FIG. 4, and as tension is applied to the drive cable 42 (thatis, the drive cable 42 is pulled proximally toward the operation of thesuturing apparatus 10) and ultimately the pin 40, the pin 40 engages thecamming member 60 forcing friction camming member 38, and moreparticularly, the engagement member 58 to travel inwardly into contactwith the exterior surface 54 of the needle 28 due to the camming actionresulting from the interaction of the pin 40 and the slot 64 within thecamming member 60 (see FIG. 5). As tension is continually applied to thedrive cable 42 the notches 62 formed along the inner surface of theengagement member 58 grab into the notches 56 cut into the exteriorsurface 54 of the needle 28, causing the needle 28 to rotate clockwiseuntil pin 40 reaches the limit of track 34 and the procedure must startall over (see FIG. 6).

When the limit of the stroke is reached as shown in FIG. 6, the operatorcompresses the drive cable 42 causing the engagement member 58 todisengage from the needle 28 by way of the cam feature resulting fromthe interaction of the pin 40 within the slot 64 of the camming member60 as the pin 40 slides within the slot 64 causing the engagement member58 and camming member 60 to move outwardly and in a counterclockwisedirection (see FIG. 7). The compression on the drive cable 42 iscontinued until the friction camming member 38 moves counterclockwisereaching the opposite end of the housing 24 (see FIG. 8). Tension isthen applied to once again move the needle 28 in a clockwise directionand the procedure is repeated until the needle has traveled 360 degrees(see FIGS. 9 and 10).

As briefly discussed above, the drive assembly 30 of the presentinvention is capable of driving the needle 28 about its circular path ina highly controlled and efficient manner. Referring to FIG. 15, thefunctionality of the present drive assembly 330 is enhanced by theprovision of the friction camming member 338, which drives the needle328 when pulling the needle 328 along its path through frictional means.The contact surface of the frictional interface 358 of the frictioncamming member 338 is manufactured to enhance its frictionalrelationship with the needle 328 so as to smoothly and reliably move theneedle 328 in accordance with the present invention.

The interaction between the friction camming member 338 and the needle328 is enhanced by the provision of a leaf spring 370. The leaf spring370 extends within the suture housing 324 of the suturing apparatus 310and is oriented to contact the friction camming member 338 duringactuation of the needle 328 for forcing the friction camming member 338into contact with the needle 328. The leaf spring 370 is a cantilevermounted spring member mounted proximally of the friction camming member338. As the friction camming member 338 is forced distally, the leafspring 370 increases the engagement forces radially the farther thefriction camming member 338 is displaced. As those skilled in the artwill certainly appreciate, a spring structure is disclosed in accordancewith a preferred embodiment of the present invention and other springstructures could be employed without departing from the spirit of thepresent invention.

In accordance with an alternate embodiment, and with reference to FIG.16, the smooth friction camming member 338 discussed above may bereplaced with a toothed friction camming member 438. In accordance withthis embodiment, the contact surface of the frictional interface 458 ofthe friction camming member 438 is provided with teeth 472 shaped anddimensioned to engage similarly shaped teeth 474 formed along theexterior surface of needle 428. In this way, the teeth 472 along thefrictional interface 458 of the friction camming member 438 engage teeth474 cut into the needle 428 and drag the needle 428 along its drive pathwhen pulled. As with the prior embodiment, the interaction between thefriction camming member 438 and the needle 428 is enhanced by theprovision of a leaf spring 470. The leaf spring 470 extends within thesuture housing 424 of the suturing apparatus 410 and is oriented tocontact the friction camming member 438 during actuation of the needle428 for forcing the friction camming member 438 into contact with theneedle 428.

In accordance with an alternate embodiment, and with reference to FIG.17, The motion of the friction camming member 538 (whether it be asmooth friction camming member 338 as shown in FIG. 15 or a toothedfriction camming member 438 as shown in FIG. 16) used in driving theneedle 528 can also be achieved through the use of a sprocket gear 570engaging with teeth 572 on the back side 574 of the friction cammingmember 538 driving the needle 528 through the same motions the linearpull system created. Such a gearing arrangement provides for thetranslation of rotary motion along the drive cable 582, and about afirst axis substantially aligned with the longitudinal axis of thesuturing apparatus 510 extending through the suturing apparatus 510,into rotary motion of the needle 528 about an arcuate path having acentral axis substantially perpendicular to the longitudinal axis of thesuturing apparatus 510. In accordance with this embodiment, the sprocketgear 570 is rotated by a rotary cable drive system 576 linked to arotary member in the handle (not shown) which would replace the linearpull system. In accordance with this embodiment, the rotary cable motion(rotating about the longitudinal axis of the device shaft) is convertedto rotary motion (rotating perpendicular to the longitudinal axis of thedevice shaft) to drive the needle 528 directly along its circular pathor to drive the toothed friction camming member 538 in its path.

More particularly, the drive cable 582 is designed for rotation about anaxis substantially parallel to the longitudinal axis of the apparatus510. The distal end 584 of the drive cable 582 is provide with spur gear586 which is linked to a similar spur gear 588 mounted between the spurgear 586 at the distal end 584 of the drive cable 582 and a gearedcontact surface 574 of the friction camming member 538. As a result,rotation of the drive cable 582 causes the spur gear 586 to rotate,which in turns translates into motion of the friction camming member538. Movement of the friction camming member 538 then causes the needle528 to move in a desired arcuate path. Since the friction camming member538 engages and disengages the needle 528 in a manner similar to theembodiment described above, movement of the needle 528 is achieved byalternately reversing the rotation of the rotary cable system. Forwardrotation cams the friction camming member 538 into engagement and drivesthe friction camming member 538 counter-clockwise in a manner drivingthe needle 528. Reverse rotation of the drive cable 582 disengages thefriction camming member 538 from the needle 528 and rotates the frictioncamming member 538 clockwise resetting it for the next driving motion.

Regardless of the friction camming member design, the drive mechanismemployed in accordance with preferred embodiments of the presentinvention provides a rotary needle drive system for suture pass-throughcapable of multiple tissue pass-through during a single deviceinsertion. As discussed above, in accordance with a preferred embodimentof the present invention, this is accomplished by a friction cammingmember that advances the needle by means of a toothed engagement or africtional coupling, and provides for needle advancement permittingvariation in the size of both the needle and suture used in accordancewith the present invention.

Two anti-backup structures are disclosed with reference to FIGS. 18 and19. These anti-backup structures control needle movement so the needleis only allowed to pass in one direction. This prevents the needle frombacking out between actuating strokes of the fricton camming member asit moves between its end (or limit) of stroke position as shown in FIG.6 and its initial drive position as shown in FIG. 8. More particularly,the needle of the present suturing apparatus is designed to move in apredetermined first direction about an arcuate path, and movement in anopposite second direction is undesired. As such, the present anti-backupstructures prevent movement of the needle in the second direction whilepermitting free movement of the needle in the first direction.

More particularly, and in accordance with a preferred embodimentdisclosed with reference to FIG. 18, a frictional anti-backup device 670is secured along the forward end of the needle 628 path for contact withthe needle 628 in a manner preventing undesired back-up thereof. Thefrictional anti-backup device 670 is a lever arm 672 including a firstend 674 and second end 676. The first end 674 of the lever arm 672 ispivotally secured to the suturing body 614 of the suturing apparatus610. The second end 676 of lever arm 672 extends toward, and intocontact with, the contact surface of the needle 628. The lever arm 672is oriented such that when the needle 628 is moved in acounter-clockwise direction as viewed in FIG. 18, the lever arm 672slides over the exterior surface of the needle 628 permitting the needle628 to freely rotate.

However, if the needle 628 attempts to rotate in a clockwise directionas viewed in FIG. 18, the second end 676 of the lever arm 672frictionally engages the exterior surface of the needle 628 in a mannerstopping clockwise rotation thereof. This is a result of the orientationof the lever arm 672 that creates a frictional impediment to movement ofthe needle 628, for example, similar to a ratchet mechanism. With thisin mind, the lever arm 672 is biased to maintain engagement with theexterior surface of the needle 628 whether the needle is rotated in aclockwise direction or a counter-clockwise direction.

In accordance with an alternate embodiment and with reference to FIG.19, the suturing body 714 is provided with an integral spring biasedlatch 770 shaped and dimensioned to fit within recesses 772 formed inthe exterior surface of the needle 728. With this in mind, the latch 770and the recesses 772 are shaped and dimensioned to permit substantiallyfree rotation of the needle 728 in one direction while preventingrotation of the needle 728 in the opposite direction.

Since it is possible the needle may become jammed within the tissueduring deployment, it sometimes becomes necessary to free the needlefrom the suturing apparatus for emergency extraction of both thesuturing apparatus and the needle. With this in mind, and with referenceto the various embodiments presented below, techniques have beendeveloped for freeing the needle in the event it becomes jammed andrequires release. In general, the embodiments described below aredifferent methods of separating or opening the suture housing of thesuturing apparatus to release the needle and allow the suturingapparatus to be removed. Release of the needle in this manner mightnecessitate subsequent removal of the needle from its jammed position,but will permit extraction of the remainder of the suturing apparatus asthe suturing apparatus is no longer hung on the tissue based upon therelease of the needle.

In accordance with the various embodiments disclosed below, a surgicalsuturing apparatus includes a suture housing and a needle mounted withinthe suture housing for movement about an arcuate path. The suturingapparatus also includes a drive assembly operably associated with theneedle for controlling movement of the needle with a suture securedthereto about the arcuate path in a manner facilitating application ofthe suture to tissue. The suture housing has an open position and aclosed position, and the needle can be removed from the suture housingwhen in the open position.

The various embodiments provide a user a controlled opening mechanismthat allows the suture housing to be selectively opened should theneedle fail to be able to advance and the suturing apparatus needs to beextracted. As will be described below in greater detail, this isachieved by employing either a spring biased, hinged clamshell suturingbody opening when a crushable coupling mechanism is actuated, aremovable pin/cable mechanism that holds the two halves of the suturingbody together or an openable suture deployment system that can bere-closed for extraction from the body.

In accordance with a first embodiment, and with reference to FIGS. 20 to22, and as discussed above in greater detail, the suturing body 814 iscomposed of a first housing member 820 and second housing member 822making up the suture housing 824. A cam pin set 870 locks the firsthousing member 820 and the second housing member 822 together, with,however, the ability to remove the cam pin set 870 from the secondhousing member 822 when it is desired to separate the first and secondhousing members 820, 822 for removal of a jammed needle 828.

More particularly, the first and second housing members 820, 822 arehinged 872 along one end thereof, and the cam pin set 870 is positionedin a manner opposite the hinge 872 so the first and second housingmembers 820, 822 are securely held together. However, when the cam pinset 870 is removed, or otherwise removed from its locking position witha second housing member 822, the first and second housing members 820,822 are free to move apart pivoting about the hinge 872. Opening of thesuturing housing 824 is further facilitated by the inclusion of a spring874 in the hinge 872 for encouraging opening of the suturing housing 824upon removal of the cam pin set 870.

Actuation of the cam pin set 870 is achieved via the use of a releasemember 876 that interacts to permit controlled locking and release ofthe cam pin set 870. In particular, the release member 876 includes aseries of interference members 878 which interact with the heads 880 ofthe cam pin set 870 to retain them within recesses 882 formed in thesecond housing member 822 (see FIG. 21). When it is desired to separatethe first and second housing members 820, 822, the release member 876 isshifted, for example, via a cable 884 extending for actuation by a user,to move the interference member 878 and allow the cam pin set 870 tomove from within the second housing member 822 (see FIG. 22).

In accordance with another embodiment, and with reference to FIGS. 23and 24, a tear strip 970 is disclosed. As with the prior embodiments,the suturing body 914 is composed of a first housing member 920 andsecond housing member 922 making up the suture housing 924. The firstand second housing members 920, 922 are hinged 972 along one endthereof, with a spring 974 biasing the first and second housing members920, 922 to an open orientation.

The tear strip 970 is positioned through the centerline of the first andsecond housing members 920, 922. In accordance with a preferredembodiment, the tear strip 970 is secured to the first and secondhousing members 920, 922 either through adhesive or other mechanicalfrangible, plastic coupling features. When pulled, the tear strip 970“tears” the center out from between the first and second housing members920, 922 allowing the suturing apparatus 910 to fall open. The tearstrip 970 may be a straight adhesive or molded strip, or the tear strip970 may include a camming feature (as discussed below) as part of thedistal most end further spreading open the halves as it is removed.

A further embodiment is disclosed with reference to FIGS. 25 and 26.This embodiment employs a pull cable 1070 to facilitate selectiveopening of the suturing body 1014 for release of a jammed needletherefrom. In accordance with this embodiment, the suturing body 1014 iscomposed of a first housing member 1020 and second housing member 1022making up a suture housing 1024. The first and second housing members1020, 1022 are hinged 1072 along one end thereof (or are separatenon-associated halves). The first and second housing members 1020, 1022are further provided with lacing loops 1074 along the open end thereof.The lacing loops 1074 are shaped and dimensioned to permit the placementof a pull cable 1070 therethrough in a manner which holds the first andsecond housing members 1020, 1022 together.

More particularly, the pull cable 1070 is laced through the lacing loops1074 alternately positioned on the first and second housing members1020, 1022 much like the hinge of a door. As long as the pull cable 1070is present around the perimeter of the first and second housing members1020, 1022, the first and second housing members 1020, 1022 are heldtogether and the needle 1028 is retained therein. However, when it isdesirable to remove the needle 1028 or otherwise open the suturing body1014 of the suturing apparatus 1010, the pull cable 1070 is pulledwithdrawing it from the lacing loops 1074 and releasing the first andsecond housing members 1020, 1022 from each other. With the first andsecond housing members 1020, 1022 released, the spring biased hinge 1072draws the first and second housing members 1020, 1022 apart by pivotingthem along the hinge 1072.

A spreader plate 1170 embodiment is disclosed with reference to FIGS. 27and 28. This is a variation on the tear strip design disclosed abovewith reference to FIGS. 23 and 24. In accordance with this embodiment,the center connection member 1172 not only joins and releases the twohousing members 1120, 1122, but has a camming member 1174 on the distalend of the center connection member 1172 that as it is pulled throughthe system actually cams the first and second housing members 1120, 1122apart not just allowing them to freely fall apart.

More particularly, and as discussed above with the various otherembodiments, the suturing body 1114 includes a first housing member 1120and a second housing member 1122 making up the suture housing 1124. Thefirst and second housing members 1120, 1122 are hinged 1176 along oneend thereof, with a spring 1178 biasing the first and second housingmembers 1120, 1122 to an open orientation (or are separatenon-associated non-spring biased halves). The central connection member1172 is positioned through the centerline of the first and secondhousing members 1120, 1122. In accordance with a preferred embodiment,the central connection member 1172 is secured to the first and secondhousing members 1120, 1122 through a member that is rigid enough toprevent inadvertent deployment of the system but can be broken ordisengaged from the distal end of the suture housing 1124. When pulled,the central connection member 1172 releases the first and second housingmember 1120, 1122 allowing the suture housing 1124 to fall open.

The opening of the suturing body 1114 upon removal of the centralconnection member 1172 is facilitated by including a camming member 1174at the distal end 1180 of the central connection member 1172. Thecamming member 1174 is positioned and shaped such that it extendsbetween the first and second housing members 1120, 1122 in a mannerpushing the first and second housing members 1120, 1122 apart forremoval of the needle 1128 or to provide other access to the internalstructure of the suturing body 1114.

Referring to FIGS. 29, 30 and 31 yet a further embodiment of the presentinvention is disclosed. The embodiment employs a series of crushableinterlocking clamps 1270 in the selective opening of the suturing body1214. As with the cam pin set, the interlocking clamps 1270 hold thefirst and second housing members 1220, 1222 together during normalfunction. When a cable 1272 secured to the interlocking clamps 1270 ispulled, the interlocking clamps 1270 are crushed, unlocking the firstand second housing members 1220, 1222 and allowing them to pivot openunder the control of the spring biased hinge 1274.

In addition to the inclusion of a release structure for the housingstructures described above, each of these embodiments is provided with ahousing outer profile, shaped and dimensioned to permit limited closingof the suturing body as it is withdrawn from the stomach. In particular,the outer profile is rounded with a convex profile designed such thatthe first and second housing member are at least partially forcedtogether when the suturing device is withdrawn through a trans-oraltube.

With the convex profile in mind, it is contemplated it may be desirableto hinge the first and second housing members along their proximal ends(see FIGS. 27 and 28). Either of the various release mechanism may beused in accordance with this embodiment. However, by positioning thehinge at the proximal end thereof the first and second housing membersare directly connected to the shaft allowing them to be easily re-closedduring extraction rather than having numerous loose parts free to moveand fall wherever.

One of the challenges of a suturing apparatus offering a needle thatmoves through a continuous circular path is to identify to the userwhere the needle is in the stroke of the device as well as give the usera method to stop at the end of one full stroke around before startingthe next stroke. Current imaging techniques allow doctors to visualize avariety of endoscopic procedures. However, the techniques and devicesmust be designed to permit visualization. In addition, and wherevisualization is important to completion of the technique, it isimportant that physical feedback be combined with the visual feedback toensure redundancy in the event visualization is not possible.

As such, the present suturing apparatus is provided with a variety ofindicators for both physical and visual identification of the procedurebeing performed. Briefly, and as will be discussed below in greaterdetail, the present endoscopic suturing device includes means foridentifying the position of the needle along its path both locally inthe surgical field and externally on the actuation mechanism. Inaddition, the endoscopic suturing device includes a secondary mechanismdesigned to stop the needle at the end of one full actuation to indicateto the user that it is the proper time in the sequence to re-positionthe device for subsequent actuations.

More particularly, and in accordance with the various embodimentsdescribed below, the surgical suturing apparatus includes a suturehousing and a needle mounted within the suture housing for movementabout an arcuate path. A drive assembly operably associated with theneedle for controlling movement of the needle with a suture securedthereto about the arcuate path in a manner facilitating application ofthe suture to tissue. A mechanism is provided for determining theposition of at least one of the distal end of the needle and theproximal end of the needle at all points along the arcuate path aboutwhich the needle moves.

Referring to FIG. 32, the endoscopic suturing device 1610 includes aspring ball lock 1670 shaped and dimensioned to provide a physicalindication of the needle 1628 position. In accordance with a preferredembodiment, a small ball bearing 1672 is spring 1674 biased into thepath of the oncoming needle 1628 to stop its motion at the end of itstravel. The ball bearing 1672 is mounted within the suturing body 1614for access to and contact with the exterior surface of the needle 1628.The ball bearing 1672 is spring 1674 biased toward the exterior surfaceof the needle 1628. As such, when the needle 1628 is moved along itsarcuate path and comes into contact with the ball bearing 1672, tactilefeedback is provided to the user. The needle 1628 is provided with arecess 1676 along its exterior surface (preferably adjacent the tip ofthe needle, although multiple recesses may be employed at variouslocations along the length of the needle to provide physical indicationsof needle position). The recess 1676 is shaped and dimensioned to permitthe ball bearing 1672 to seat therein when the needle recess 1676 comesinto alignment with the ball bearing 1672 providing the user withtactile feedback of the needle positioned 1628. In accordance with apreferred embodiment, the ball bearing 1672 is positioned adjacent theentry point for the needle 1628 as it begins its throw loop and therecess 1676 of the needle 1628 is formed therealong at a position suchthat the operator is provided with additional tactile feedback that acomplete needle loop is achieved.

It is contemplated the ball bearing may be used in combination with acamming mechanism to move it out of the path for the next stroke tooccur or it can be used at a restricting force that only appliesfeedback to the user that the end of a stroke has been achieved, but canbe overcome by the user though the application of more force.

In accordance with an alternate embodiment, and with reference to FIG.33, a spring ratchet pawl lock 1770 is oriented to interfere withmovement of the needle 1728 for identifying needle 1728 position and thecompletion of a needle loop. More particularly, a pawl lock lever arm1772 is secured along the forward end of the needle path for contactwith the needle 1728 in a manner providing a physical indication as tothe position of the needle 1728. The pawl lock lever arm 1772 is securedalong the forward end of the needle path for contact with the needle1728 in a manner providing a physical indication. The pawl lock leverarm 1772 includes a first end 1774 and second end 1776. The first end1774 of the lever arm 1772 is pivotally secured to the suturing body1714 of the suturing device 1710. The second end 1776 of lever arm 1772extends toward and into contact with the exterior surface of the needle1728. The lever arm 1772 is oriented such that when the needle 1728 ismoved in a counter-clockwise direction, the lever arm 1772 slides overthe exterior surface of the needle 1728.

However, and as with the prior embodiment, the exterior surface of theneedle 1728 is provided with a recess 1778 along its exterior surface.The recess 1778 is shaped and dimensioned to permit the second end 1776of the lever arm 1772 to seat therein when the needle recess 1778 comesinto alignment with the second end 1776 of the lever arm 1772. Asmentioned above, and in accordance with a preferred embodiment, thelever arm 1772 is positioned adjacent the entry point for the needle1728 as it begins its throw loop and the recess 1778 of the needle 1728is formed therealong at a position such that the operator is providedwith a tactile feedback that a complete needle loop is achieved.

Referring to FIGS. 34, 35, 36 and 37, the suturing apparatus includes apop out indicator pin 1870. The pin 1870 is shaped and dimensioned topop out the side of the suturing body 1814 when the needle 1828 is inits advanced position giving the surgeon visible feedback as to theneedle 1828 position within the surgical site of the endoscope. Once theneedle 1828 is fully advanced, the pin 1870 is spring biased to thehidden or in position indicating the suturing apparatus 1810 is readyfor repositioning (see FIGS. 34 and 35). Visualization thereof isprovided by coloring the exposed portion 1871 of the pin 1870 in adistinctive color to allow ready identification that the needle 1828 ispositioned in a desired orientation.

More particular, the pin 1870 is spring biased within an aperture 1872formed in the wall of the suturing body 1814. The pin 1870 is biased toa hidden position and includes a first end 1876 and a second end 1878.The first end 1876 is positioned for contact with the needle 1828 as itmoves along its arcuate path, while the second end 1878 is positionedadjacent the outer surface of the aperture 1872 for movement between ahidden position and an exposed position. With this in mind, the secondend 1878 of the pin 1870 is colored in a distinctive manner allowingready visualization thereof.

Movement of the pin 1870 is facilitated by the movement of the needle1828 into contact with the first end 1876 of the pin 1870. Inparticular, the first end 1876 of the pin 1870 is seated within the pathof the needle 1828, although it is shaped and dimensioned to readilymove once the needle 1828 moves into contact therewith (without undulyinterfering with the movement of the needle as it makes its arcuatepath).

In accordance with another embodiment and with reference to FIG. 38, theneedle 1928 is colored to provide ready visualization thereof. Moreparticularly, the needle 1928 is made with contrasting color to thesurgical field to improve the visibility of the surgeon to identifywhere the needle 1928 is currently positioned. In accordance with apreferred embodiment, the tip 1970 is colored with the contrasting colorto provide a ready identification the needle is exiting the suturingbody.

Referring to FIG. 39, yet a further embodiment is disclosed. Inaccordance with this embodiment, the needle 2028 position is calibratedwith an indicator 2070 secured at the handle of the suturing apparatus2010. It is contemplated the indicator 2070 might be severalhemispherical patterned lights, a dial indicator or other circular pathindicator. In accordance with this embodiment, the suturing body 2014 isprovided with one or multiple Hall effect sensors 2074 working inconjunction with the needle 2028 to provide the operator with anindication of the needle 2028 position. As the steel or magnetized steelneedle 2028 passes adjacent the three sensors 2074 shown in FIG. 39 thesystem lights up the appropriate needle position indicator lights 2070on handle 2072. Although Hall effect sensors are disclosed in accordancewith a preferred embodiment of the present invention, other electronicmeans known to those skilled in the art could be used within the spiritof the present invention. For example, the sensors could be mechanicalspring biased switches, or even extremely low voltage contact orinductance switches that make contact through needle itself makingcontact with both side of the switches (one placed on either side of theneedle track).

Improved functionality of the present suturing apparatus is achieved bythe provision of a mechanical attachment mechanism specifically adaptedfor attaching the vacuum chamber and suturing body to the end of theendoscope, allowing for rotational positioning of the endoscopicsuturing device with respect to the endoscope. The various embodimentsdescribed below provide for a mechanical attachment mechanism thatattaches the vacuum chamber and suturing body at the end of theendoscope, allowing for flexible positioning of the vacuum chamber andsuturing body away from the endoscope to increase visibility of thepocket. In accordance with one embodiment described below, themechanical attachment mechanism includes a flexible connection arm thatcollapses against the endoscope during insertion for a low profileinsertion, but then springs away from the endoscope once in the body toimprove visibility of the vacuum chamber and suturing body forpositioning and suture deployment.

In accordance with another embodiment, the mechanical attachmentmechanism attaches the vacuum chamber and suturing body to the end ofthe endoscope through the use of a detachable mechanism that can beremoved and passed into a body cavity prior to the introduction of theendoscope, or for interchanging the suturing apparatus with anothersuturing body or even another endoscopic device. This could also allowfor interchanging between a vacuum assist suture device and anon-assisted device.

The mechanisms provide for a unique method for access to a body cavitythrough either a natural orifice or a surgical initiated orifice. Inparticular, the present invention provides a method for inserting asuturing apparatus, or other surgical instrument, through a bodyorifice. The instrument has a low profile orientation and a deployedorientation which is larger than the size of the body orifice throughwhich it is to be inserted. The method is achieved by coupling theinstrument to an endoscope and placing the instrument in its low profileorientation, inserting the endoscope and the instrument through anatural orifice to a target position within a body while the instrumentis in its low profile orientation, and actuating the instrument to it isdeployed orientation. Finally, the instrument is returned to its lowprofile orientation and withdrawn from the body through the naturalorifice.

Referring to FIG. 40, a first embodiment in accordance with the presentinvention is disclosed. In accordance with this embodiment, a scopeattachment ring 2170 is secured about the distal end 2172 of theendoscope 2174 to which the present suturing apparatus 2110 is to bemounted. The attachment ring 2170 generally includes a ring body 2176having parallel apertures 2178, 2180 respectively shaped for the receiptof the endoscope 2174 and the support shaft 2182 of the present suturingapparatus 2110 to which the suturing body 2114 and vacuum chamber 2146are attached. With regard to the endoscope 2174, the first aperture 2178is shaped for frictional engagement with the outer surface of theendoscope 2174 in a manner preventing rotation of the attachment ring2170 relative to the endoscope 2174.

The second aperture 2180 is shaped and dimensioned for receiving theshaft 2182 of the suturing apparatus 2110, and in accordance with apreferred embodiment thereof, the second aperture 2180 is slightlylarger than the shaft 2182 of the suturing apparatus 2110. In this way,the suturing apparatus 2110 may be rotated relative to the endoscope2174 for improved access to tissue. Positioning of the suturingapparatus 2110 relative to the attachment ring 2170 is achieved bypositioning abutment members 2184, 2186 along the shaft 2182 of thesuturing apparatus 2110 on opposite sides of the attachment ring 2170.These members 2184, 2186 can be coupled to the shaft 2182 via screwthreads during manufacturing, pressed into place during manufacturing orbe molded as part of the attachment ring itself. In this way, thesuturing apparatus 2110 may be freely rotated relative to the endoscope2174 while the suturing apparatus 2110 is substantially prevented fromlongitudinal movement relative thereto.

In accordance with another embodiment and with reference to FIGS. 41, 42and 43, an endoscope attachment ring 2270 similar to that describedabove is secured about the distal end 2272 of the endoscope 2274 towhich the present suturing apparatus 2210 is to be mounted. Theattachment ring 2270 generally includes a ring body 2276 having parallelapertures 2278, 2280 respectively shaped for the receipt of theendoscope 2274 and the present suturing apparatus shaft 2282. Withregard to the endoscope 2274, the aperture 2278 is shaped for frictionalengagement with the outer surface of the endoscope 2274 in a mannerpreventing rotation of the attachment ring 2270 relative to theendoscope 2274.

As for the second aperture 2280 receiving the shaft 2282 of the suturingapparatus 2210, and in accordance with a preferred embodiment thereof,the second aperture 2280 is approximately the same size as the shaft2282 of the suturing apparatus 2210. In this way, the suturing apparatus2210 is prevented from rotating relative to the endoscope 2274 allowingfor the elastic deployment off the axis of the endoscope 2274 to permitbetter visualization. Positioning of the suturing apparatus 2210relative to the attachment ring 2270 is achieved by positioning abutmentmembers 2284, 2286 along the shaft 2282 of the suturing apparatus 2210on opposite sides of the attachment ring 2270. In an alternateembodiment the fit between the endoscope attachment ring and the elasticarm could be a loose fit as discussed above with regard to theembodiment shown in FIG. 40 permitting it to be freely rotated relativeto the endoscope while the endoscopic suturing device is substantiallyprevented from longitudinal movement relative thereto.

Improved access of the suturing apparatus is further facilitated bymanufacturing the shaft 2282 distal from the second aperture 2280 of theattachment ring 2270 from a flexible material that is biased to aposition removed from the endoscope 2274. In this way, the suturingapparatus 2210 may be held close to the endoscope 2274 during insertion,reducing the profile of the structure being inserted trans-orally, whileallowing for movement of the suturing apparatus 2210 away from theendoscope 2274 when the suturing apparatus 2210 reaches its desiredlocation.

More particularly, the portion of the shaft 2282 a providing for flexingof the suturing body 2214 away from the endoscope 2274 is an elastomerlever arm designed to move the suturing apparatus 2210 off axis from theendoscope 2274 in a manner improving visualization of the suturingapparatus 2210 and its usage while still allowing it to deflect againstthe endoscope during insertion and extraction, reducing its overallprofile during these activities.

In accordance with an alternate embodiment of the present invention andwith reference to FIGS. 41a and 42a , the attachment ring 2270 a may beconstructed with a connection member 2283 a extending distally fromsecond aperture 2280 a. The connection member 2283 a is an elastomerlever arm designed to move the suturing apparatus 2210 a, with the shaft2282 a thereof extending through the connection member 2283 a off axisfrom the endoscope 2274 a in a manner improving visualization of thesuturing apparatus 2210 and its usage while still allowing it to deflectagainst the endoscope 2274 a during insertion and extraction, reducingits overall profile during these activities.

As briefly mention above, the connection member 2283 a is shaped anddimensioned to fit about the shaft 2282 a of the suturing apparatus 2210a. The connection member 2283 a is constructed of a resilient materialand is biased to a position removed from the endoscope 2274 a. In thisway, the connection member 2283 a with the shaft 2282 a of the suturingapparatus 2210 extending therethrough may be held close to the endoscope2274 a during insertion, reducing the profile of the structure beinginserted trans-orally. However, once the suturing body 2214 a ispositioned within the body cavity, the connection member 2283 a isreleased, allowing it to extend away from the endoscope 2274 a. Becausethe shaft 2282 a of the suturing apparatus 2210 is positioned within theconnection member 2283 a, the shaft 2282 a and the suturing body 2214 aare moved away from the endoscope 2274 a as the connection member 2283 amoves away from the endoscope 2274 a.

In addition to the various embodiments discussed above and withreference to FIGS. 44, 45 and 46, it is contemplated a guidewireintroducer 2470 for a suturing apparatus 2410 may be employed. Such adevice is used in combination with a detachable vacuum chamber 2446 andsuturing body 2414 detailed above. The distal end components, that is,the vacuum chamber 2446 and the suturing body 2414 are passed, forexample, through the oral cavity in advance of the endoscope 2472 andsubsequently attached to the endoscope attachment ring 2474 via a guidewire 2470 which is pulled through a support shaft 2476 in a mannerdrawing the suturing body 2414 and vacuum chamber 2446 onto the supportshaft 2476. The endoscope 2472 itself can be used to advance thedetached vacuum chamber 2446 and a suturing body 2414 down the oralcavity. The pre-positioned guide wire 2470 within the working channel ofthe endoscope 2472 is terminated at its distal end 2471 by connection tothe vacuum chamber 2446 and suturing body 2414. Once passed into thestomach, the vacuum chamber 2446 and suturing body 2414 are pulled backinto attachment to the distal end of the endoscope 2472 and onto asupport shaft 2476 by pulling the suturing body 2414 and vacuum chamber2446 into engagement with the endoscope 2472 through the action of theguidewire 2470 to which the vacuum chamber 2446 and suturing body 2414are connected. This allows for use of a vacuum chamber 2446 and suturingbody 2414 that are laterally and thickness wise larger than could bepassed in fixed attachment to the endoscope during insertion.

As an alternative embodiment, the vacuum chamber can be interchangeableused with non-vacuum equipment that looks similar or identical to thevacuum version, but does not utilize the vacuum to position the tissueand merely relies upon placing the chamber adjacent to the tissue to besutured. This drastically reduces the bite size, but also reduces thepossible trauma to the tissue that vacuuming the tissue into the pocketmay cause.

In particular, there are some procedures that would preferably be usedwithout a vacuum assist to pull the tissue into the vacuum chamber, butrather would merely throw the suture with minimal tissue bite depth.There are even clinical situations where the vacuum could induce damageto the tissue. An interchangeable vacuum chamber that has a differingcavity depth and profile could be used with the suturing apparatuswithout a vacuum assist.

A quick handle disconnect is also contemplated in accordance withpresent invention and is shown with reference to FIGS. 47, 48, 49, 50and 51. This feature may be used in combination with or separately fromthe guidewire introducer as described above. Briefly, this embodimentemploys a suture housing 2524, a needle 2528 mounted within the suturehousing 2524 for movement about an arcuate path, a drive assemblyoperably associated with the needle 2528 for controlling movement of theneedle 2528 with a suture secured thereto about the arcuate path in amanner facilitating application of the suture to tissue, a handle 2570,an elongated flexible member, for example, a drive cable 2542 having adistal end attached to the suture housing 2524 and a proximal endattached to the handle 2570, and a mechanism for releasing andreattaching the handle 2570 to the flexible member 2542.

The utilization of a quick handle disconnect facilitates distaldetachment and pre-passing of the suturing apparatus 2510 through theselective attachment and detachment of the handle 2570 from the flexibledrive cable 2542 to which the suturing body 2514 and vacuum chamber 2546are connected. In accordance with this embodiment, the drive cable 2542may function much like the guidewire previously discussed in allowingone to pass the suturing body 2514 and the vacuum chamber 2546 intoposition prior to complete assembly. This improvement allows one topre-pass the suturing apparatus 2510 from the distal end of theendoscope in manner reducing the required profile because the suturingapparatus 2510 is positioned distal of the endoscope during passagethereof rather than passing the suturing apparatus 2510 from theproximal end of the endoscope in a manner increasing the requiredpassageway since the profile must accommodate both.

More particularly, the handle 2570 is composed of a handle body 2574 inwhich the drive cable 2542 is releasably secured for actuation. Withthis in mind, the handle body 2574 includes a central passageway 2578 inwhich the drive cable 2542 is stored and mounted. The handle body 2574is composed of a central grip 2580 and a slide member 2581 that movesrelative to the central grip 2580 in a manner discussed below in greaterdetail. The central passageway 2578 includes a first open end 2582 and asecond closed end 2584. Adjacent the second closed end 2584 is a springloaded trigger lock 2586 secured to the central grip 2580. The triggerlock 2586 is shaped and dimensioned to engage a protrusion 2594 (forexample, a bullet nose tip) along the proximal tip 2588 of the drivecable 2542. In this way, the proximal tip 2588 of the drive cable 2542is mounted within a recess 2590 in the proximal end 2592 of thepassageway 2578 and within the central grip 2580 (for centeringthereof), and the trigger lock 2586 is moved downward into engagementwith the protrusion 2594 for maintaining the drive cable 2576 within thehandle body 2574. When it is desired to remove the handle 2570 from thedrive cable 2578, one need only actuate the trigger lock 2586 to itsrelease position and the handle body 2574 may be freely removed from thedrive cable 2542. Retention of the drive cable 2542 within the handlebody 2574 is further facilitated by the inclusion of a locking slide2596 along the slide member 2581. The locking slide 2596 frictionallyinteracts with a collar 2598 formed on drive cable 2542 for retention ofthe handle body 2574 thereon.

In practice, the distal end of the drive cable 2542 is inserted withinthe passageway 2578 formed in the slide member 2581. The drive cable2542 is inserted to such a point that the collar 2598 of the drive cable2576 is aligned with openings 2583 formed along the slide member 2581.At this point, the locking slide 2596 is slid along the slide member2581 and is moved over the collar 2598 into engagement therewith. Thedrive cable 2542 is, at this point, secured to the slide member 2581.The slide member 2581 is then moved proximally relative to the centralgrip 2580 until the proximal end 2588 of the drive cable 2542 is seatedwithin the recess 2590 formed in the central grip 2580. The trigger lock2586 is then spring actuated to engage the protrusion 2594 at theproximal tip 2588 of the drive cable 2542 for securing it to the centralgrip 2580 and the handle body 2574.

Once the handle 2570 is secured to the drive cable 2542, release thereofis achieved by reversing the attachment steps discussed above. Inparticular, the trigger lock 2586 is rotated forward to permit releaseof the protrusion 2594 from within the recess 2590 of the central grip2580.

As discussed above, the present handle 2570 allows for actuation of thedrive cable 2542 in a manner operating the present suturing apparatus2510. In particular, relative movement of the central grip 2580 and theslide member 2581 while the drive cable 2542 is seated within thecentral grip 2580 causes actuation thereof permitting the drive assemblyto function in the manner described above.

Although the selectively releasable connection is described above withreference to the handle of a suturing apparatus, it is contemplated thereleasable connection could similar be applied in the selectiveconnection of the suturing body to the shaft connecting the suturingbody to the handle. In this way, one could selectively connect thesuturing body to the shaft once the suturing body is positioned withinthe body cavity and ready for use in the application of a suture totissue.

The vacuum pressure available in different operating room suites variesgreatly from location to location. Improvements to the vacuum chamberminimizing the necessary vacuum required have been discussed above.However, such structural changes might not be sufficient to ensure thepresent endoscopic suturing apparatus can be used in any location. Theembodiments detailed herein are improvements to the handle to locallyincrease the vacuum in the vacuum chamber.

Each of these embodiments provides an endoscopic instrument, forexample, a suturing apparatus, adapted for use with an endoscope. Theinstrument includes an elongated tube having a distal end and a proximalend, an end effector, for example, the suturing body of the suturingapparatus, attached to the distal end of the elongated tube, and ahandle attached to the proximal end. The handle includes a mechanism forattaching the instrument to a first vacuum source. The handle furtherincludes a second vacuum source integral with the handle for amplifyingthe first vacuum source, whereby the first and second vacuum sourcescombine to operate the end effector.

Referring to FIG. 64, this problem is addressed by the provision of asyringe based handle vacuum assist device 2970. In accordance with apreferred embodiment of the present invention, a syringe mechanism 2972is placed in parallel to the main vacuum attachment 2973 to the suturingapparatus 2910. This allows the normal operating room vacuum source tobe used to accomplish as much as it is capable of and, if additionalvacuum is still necessary to get a good tissue bite, the syringemechanism 2972 can be pulled by the surgeon to increase the vacuum inthe vacuum chamber 2946. Since the normally available vacuum source ofthe operating room is the primary mechanism for drawing tissue into thevacuum chamber 2946, the volume necessary in the syringe mechanism 2972is minimized as the tissue will already be engaged in the vacuum chamber2946, although not to its full depth. An additional benefit of thismethod of assisting an operating room vacuum source is that fluids willhave already been evacuated from the vacuum chamber 2946 by the normalor primary operating room suction means and the syringe mechanism 2972will not be filled with bodily fluids.

In accordance with another embodiment, and with reference to FIG. 65, abattery 3071 powered multi-stroke vacuum assist device 3070 for suctionactuation is provided. The vacuum assist device 3070 includes a rotaryfluid pump 3072 (lobe pump, gear pump, peristalsis pump, etc.) to beused in a multi-stroke fashion to increase the maximum volume of gassesthat can be extracted from the vacuum chamber after the primary vacuumsource of the operating room is completely engaged. This has the samebenefits of the syringe based system, but provides for the ability toexchange a greater volume of gas.

Similarly, and with reference to FIG. 66, a battery 3171 operateddisposable vacuum pump 3170 is associated with a disposable deploymenthandle 3172 used in conjunction with the present suturing apparatus3110. Like the mechanical multi-stroke mechanism detailed above, abattery operated, motor driven, disposable fluid pump 3170 is includedin the handle 3172 to supplement the vacuum available from the operatingroom.

Although FIGS. 65 and 66 disclose systems that are automaticallyactuated to create a secondary vacuum source, FIG. 67 discloses atrigger actuated system 3070 a. The trigger 3074 a employs triggerhandles 3076 a in conjunction with a gearing arrangement 3078 a to drivea fluid pump, for example, a single lobe fluid pump 3072 a. As with theprior embodiments, actuation of the trigger 3074 a and the fluid pump3072 a increases the maximum volume of gases that may be extracted fromthe vacuum chamber after the primary vacuum source of the operating roomis completely engaged. This has the same benefits of the syringe basedsystem and the automated system, but provides for manual actuationoffering a surgeon greater control.

It is further contemplated the vacuum assist may be created via asqueeze bulb with a one-way valve or a bellow mechanisms with a one-wayvalve or a secondary suction line. In addition, an idling vane 3172 acould also be incorporated to intermittently provide vacuum assist (seeFIG. 68).

As discussed above, visualization of the suturing apparatus 3510 isoften critically important to the proper use thereof. With this in mind,the suturing apparatus 3510 may be modified to improve imaging thereof.In particular, the apparatus 3510 includes a flexible member 3516, forexample, a support shaft or endoscope, having a distal end attached to asuturing body 3514 for insertion of the suturing body 3514 through anorifice and into a body cavity. The suturing body 3514 includes a suturehousing 3524 in which a needle 3528 and drive assembly are housed formovement of the needle 3528 with a suture secured thereto about anarcuate path facilitating application of the suture to tissue. Anon-visible spectrum sensing member 3570 is associated with the suturingbody 3514 for communicating a parameter of the procedure to a visualdisplay 3572. In accordance with a preferred embodiment, the non-visiblespectrum sensing member is wirelessly linked to the visual display.

For example, it is contemplated the suturing apparatus 3510 may bemodified through implementation of ultrasonic transducers 3570 in thesuturing body 3514 (see FIGS. 83 and 84). Similarly, the suturingapparatus 3510 may be modified by the inclusion of a magnetic resonanceimaging source transducer based within the suturing body or vacuumchamber to image the local suture site. Further, it is contemplated theendoscopic suturing device may be modified with the inclusion of aninfrared based imaging sensor within the suturing body or vacuum chamberto evaluate blood flow to the sutured area post suture deployment or toidentify blood rich areas in the interior lining pre-suture deploymentfor blood flow visualization. The endoscopic suturing device may alsoinclude Laser Doppler, oxygen, or carbon dioxide based sensors locatedwithin the suturing device to evaluate the blood flow characteristicsbefore or after the suture line is deployed.

These various visualization techniques provide for non-visible (outsidethe normal visible spectrum) imaging integrated into the suturingapparatus to improve the visualization of the site during suturing. Asmentioned above, the contemplated mechanisms could be ultrasonic,infrared, MRI, Laser Doppler, oxygen and carbon dioxide sensors or othersensor system. In addition, the sensors provide for tissue penetrationvisualization means for viewing the location of surrounding organgeometry and Tissue penetration visualization means for viewing thesuture deployment depth and bite size.

Referring to FIG. 85 a cartridge 3670 for the loading of needles 3628and sutures 3612 of different sizes is disclosed. In accordance with apreferred embodiment, a reloadable cartridge 3670 is capable of loadingdiffering size needles 3628 and differing size sutures 3612. Thecartridge 3670 is shaped and dimensioned for ready attachment within thechannel 3672 in which the needle 3628 is mounted in accordance with theembodiment disclosed. In particular, the suturing body 3614 is providedwith a cover 3674 providing access to and closure of the channel 3672 inwhich the needle 3628 is located. Through the implementation of acartridge based system the detachable cartridge 3670 can be removed andreplaced with a fresh needle 3628 and suture 3612 or even a differentsize of needle or suture.

In accordance with a preferred embodiment, the needle 3628 is supportedin a track member 3676, which readily seats within the channel 3672 tocreate an assembly substantially similar to that disclosed above withreference to FIGS. 3 to 10.

The cartridge based system may further be adapted to allow for theadjustment of the needle size through a simple cartridge replacement. Inparticular, and with reference to FIG. 86, the track 3780 of thecartridge 3770 is provided with a spacer wedge 3782 taking up the spacelost with the inclusion of a smaller needle 3728. The spacer wedge 3782is shaped and dimensioned to interact with the friction camming member3738 in a manner allowing the suturing apparatus 3710 to operate inaccordance with this spirit of the present invention.

While a cartridge based system is disclosed above, the suturing body ofthe suturing apparatus could be designed to permit simple replacement ofthe needle alone. Referring to FIGS. 87 and 88 this is achieved throughthe provision of an openable suturing body 3814. Rather than having acartridge based reload, this embodiment for reloading merely controlsthe needle 3828 and suture 3812, making quick loading of a devicewithout a removable section. The needle 3828 would be coupled to thereloader 3870 via a clamp 3872 that could be released or easily brokenand the suture 3812 would be maintained on the handhold section 3874 ofthe reloader 3870. This would facilitate manipulation of the needle 3828without touching it directly and would provide some form of suturemanagement prior to being loaded into the suturing apparatus 3828.

One of the difficulties in performing endoscopic procedures isefficiently and securely forming knots once the suturing is completed.It is desired the two ends, or leads, of the suture could be pulledtight simultaneously and a knotting element could then be used totighten the adjacent ends. This would maximize the number of stitchesthat could be thrown before the suture needs to be cinched down sinceboth ends of the suture could be pulled in a manner equally cinchingfrom both ends of the suture.

In accordance with a preferred embodiment of the present invention, asuture is secured by inserting the suture through a passageway into thebody of a patient. The suture is then thrown into and back out oftissue. Finally a knot is tied along the length of suture in a mannersecuring the suture in place. The knot is then fused through theapplication of energy mechanically linking the first and second leads ofthe suture forming the knot. In accordance with a preferred embodiment,the term “fusing” is meant to refer to any technique by which the sutureand/or knotting element are brought together in a manner whereby theirmaterial components are fixedly connected.

In accordance with preferred embodiments of the present invention, tyingof the knot is achieved in a variety of manners, wherein the first andsecond leads are entangled in a manner holding the leads relative toeach other. As such, those skilled in the art will appreciate that avariety of knotting techniques may be used in accordance with thepresent invention. For example, a traditional tying technique may beused wherein the first and second leads of the suture are tied in amechanical knot which is subsequently fused.

In accordance with a preferred embodiment, and with reference to FIG.62, a suture hooking device 2710 is disclosed for tying first and secondleads 2730, 2732 of a suture together. The hooking device 2710 utilizestwo parts to lock the suture together in a cap like fashion. Theadvantage to this method is that the cap 2712 has two extension arms2714, 2716 that allow it to be twisted about its axis winding the suture2718 mid-lengths onto its shaft. The cap 2712 would then be crushed intothe outside collar 2720 locking the suture ends 2718. This would allowfor fine tensioning just prior to locking the suture together.

More particularly, the suture hooking device 2710 includes an outsidecollar 2720 and a cap 2712 shaped and dimensioned to fit within theoutside collar 2720. The outside collar 2720 is generally cylindricaland includes an open upper edge 2722 and a close base 2724. The cap 2712includes an upper disk 2726 and a downwardly depending central shaft2728. The upper disk 2726 is shaped and dimensioned to fit within theopen upper edge 2722 of the outside collar 2720 such that it isfrictionally retained therein. The central shaft 2728 is smaller andfunctions as a guide for suture 2718 wrapped thereabout.

The cap 2712 further includes opposed downwardly extending extensionarms 2714, 2716. These arms 2714, 2716 provide for wrapping of thesuture 2718 about the cap 2712 upon rotation of the cap 2712. Once thesuture 2718 is wrapped about the cap 2712, the disk 2726 is fixed withinthe outside collar 2720, securing the suture 2718 in a “knotted”arrangement.

Although various mechanical knotting techniques are disclosed above, itis contemplated other fastening techniques may be used without departingfrom the spirit of the present invention. For example, and withreference to FIG. 63, fusing of the tied suture is preferably achievedby RF, ultrasonic, or electrocautery for melting of suture knot 2810 toimprove knot holding capability. This method would allow for a normalendoscopic knot to be tied adjacent the cinched tissue area. But sinceit would have a tendency to untie, an energy source (cautery,ultrasonic, RF, or other heat source) would then be applied to the knotfusing the knot together.

The lacing pattern, the cinching method, and the anchoring means of thesuture all contribute greatly to ease of use of the device. With this inmind, various suturing techniques have been developed. The presentdisclosure is meant to detail at least the preferred lacing method andan alternate anchoring method for cinching both ends simultaneously.

In accordance with the various lacing technique described below, thepresent method is achieved by providing a suture with a needle attachedthereto. The suture includes a first lead and a second lead. The needleand suture are then inserted into an organ through a passageway. Asingle stitch is thrown through a first tissue member and a singlestitch is thrown through an opposed and spaced apart second tissuemember. The step of throwing stitches is repeated at least once and thefirst and second tissue members are brought into contact by tensioningthe suture, whereby suture drag is minimized during the tensioning andeven tissue compression substantially achieved. Finally, the suture issecured in positioned with the first and second tissue members inapposition.

In accordance with a first embodiment shown in FIG. 52, resistance tocinching of a stitched suture 4212 is achieved via a throw reversing pintechnique. The technique is initiated using traditional stitchingtechniques. That is, the needle and suture 4212 are inserted andalternating stitches are thrown along opposed tissue members 4274, 4276.The stitches are consistently thrown in the proximal to distaldirection, that is, the stitch is initiated by inserting the needlethrough the tissue proximally to the point at which the needle stitch iscompleted by reentering the tissue. Although the terms distally andproximally are used in the present description, those skilled in the artwill appreciate that these terms are relative and ultimately thespecific direction of stitching may be reversed without departing fromthe spirit of the present invention.

However, the final throw 4270 of the suture 4212 (that is, the finalloop or last stitch of the suture through the tissue) is altered toreduce friction during final cinching of the suture 4212. Moreparticularly, and in accordance with a preferred embodiment of thepresent invention, drag and friction are reduced by positioning areversing pin 4272 between the suture 4212 and the tissue wall 4274after the last stitch 4270 is completed. This allows the suture 4212 tobe cinched without it overlapping itself and twisting up. Such anarrangement will significantly reduce the friction necessary to overcomeand cinch closed the lacing.

In accordance with another embodiment, and with reference to FIG. 53,resistance to cinching of a stitched suture 4312 is achieved via a throwreverse throw-over technique. The technique is initiated usingtraditional stitching techniques. That is, the needle and suture 4312are inserted and alternating stitches are thrown along opposed tissuemembers 4374, 4376. The stitches are consistently thrown in the proximalto distal direction, that is, the stitch is initiated by inserting theneedle through the tissue proximally to the point at which the needlestitch is completed by reentering the tissue. That is, the needle andsuture 4312 are inserted and alternating stitches are thrown alongopposed tissue members. The stitches are consistently thrown in theproximal to distal direction, that is, the stitch is initiated byinserting the needle through the tissue proximally to the point at whichthe needle is stitch is completed by reentering the tissue. However, thefinal throw 4370 of the suture 4312 is reversed to reduce frictionduring final cinching of the suture; that is, the final throw 4370 iscompleted by inserting the needle through the tissue in a directiondistal to the point at which the needle stitch is completed byreentering the tissue.

More particularly, the final stitch 4370 is reversed in the direction inwhich it is thrown such that it is directed toward the position fromwhich the surgeon will be pulling upon the suture line to cinch thesuture 4312. This allows the suture to be cinched without it overlappingitself and twisting up. Such an arrangement will significantly reducethe friction necessary to overcome and cinch closed the lacing.

In accordance with an alternate embodiment, and with reference to FIG.54, an initial locking loop 4470 is employed to enhance the ability ofone to cinch the suture 4412 upon completion of the stitching. Inparticular, a first lead 4412 a of the suture 4412 is anchored to thetissue along the first lead 4412 a of the suture line rather thanneeding to have both ends accessed by the user throughout the procedure.More particularly, the first lead, or leading end, 4412 a of the sutureline is stitched and a portion thereof is anchored to the tissue.Thereafter the stitching is completed, with the final stitch 4470 andthe second lead, or trailing end, 4412 b of the suture line is accessedfor cinching thereof. However, and in contrast to traditional cinchingtechniques, only the second lead 4412 b of the suture line need bepulled to cinch the suture 4412. As shown in FIGS. 52 and 53, such aninitial locking may be employed with other lacing techniques within thespirit of the present invention.

It is contemplated each set of sutures may be locally cinched before thenext set is deployed from the suturing apparatus. This minimizes, butdoes not eliminate the need for the last stitch steps discussed above.

As shown in FIGS. 55 to 61, the preceding techniques for lacing opposedtissue members may be expanded in various ways. For example, and withreference to FIG. 55, the suture 4512 may be applied in separatesegments 4513 with the first and second ends 4512 a, 4512 b of eachsegment 4513 anchored to respective first and second tissue members4574, 4576. The first end 4512 a of the suture 4512 is subsequentlytensioned and tied off to cinch the suture. By using segments ofstitches in this manner (and as discussed below in accordance with otherembodiments), local cinching of each segment of stitches may beperformed in a manner which may assist in improving the drawing oftissue together.

Referring to FIG. 56, the suture 4612 may be applied in separatesegments 4613 with the first and second ends 4612 a, 4612 b of thesuture 4612 coupled via a knotting element 4614. The first and secondends 4612 a, 4612 b are subsequently tensioned to cinch the suture 4612and the knotting element 4614 and suture 4612 are fused to secure thesuture in position.

With reference to FIG. 57, the suture 4712 is once again applied inseparate segments 4713. The first end 4712 a of the suture 4712 isprovided with a loop 4716 through which the remaining portion of thesuture 4712 is passed to couple the first end 4712 a of the suture 4712to a first tissue member 4774. As to the second end 4712 b of the suture4712, it is secured via a knotting element 4714 as discussed above. Moreparticularly, the second end 4712 b is secured to the knotting element4714 with a looping structure composed of a first loop 4718 which iscoupled to the knotting element 4714 while a portion of the second end4712 b passes through the second tissue member 4776 to form a secondloop 4720, the end of which is also coupled to the knotting element4714. Thereafter, the second end 4712 b may be tensioned, in particular,the first loop 4718 may be drawn through the knotting element 4714 andthe knotting element 4714 and suture 4710 are fused to secure the suture4710 in position.

With reference to FIG. 58, the suture 4812 is applied in separatesegments 4813 with the first and second ends 4812 a, 4812 b of thesuture 4812 coupled via a knotting element 4814. However, the finalthrow 4870 of the suture 4812 is reversed as discussed above with regardto FIGS. 53 and 54. The first and second ends 4812 a, 4812 b aresubsequently tensioned to cinch the suture 4812 and the knotting element4814 and suture 4812 are fused to secure the suture 4812 in position.

Referring to FIG. 59, the suture 4912 may be applied in separatesegments 4913 with the first and second ends 4912 a, 4912 b of eachsegment 4913 anchored to respective first and second tissue members4974, 4976. However, each throw of the suture 4912 is reversed asdiscussed above with regard to FIGS. 53 and 54, and extends in a distalto proximal direction as the suture is applied in the distal direction.The first end 4912 a of the suture 4912 is subsequently tensioned andtied off to cinch the suture 4912. Referring to FIG. 60, the same lacingtechnique is applied with the exception it is not completed in segments.

As shown in FIG. 61, an overhand knot 5022 may be used to secure thesecond end 5012 b of the suture 5012, while the first end 5012 a of thesuture 5012 is anchored to the tissue.

In accordance with the present invention, it is preferred to applymedical fluid/sealant for improving the suture lines ability to engageand retain the tissue. Particular, the suture line is subjected tosubstantial strain for a short period of time after its applicationwhile the tissue applies substantial tension in its attempt to retain toits original configuration. This generally lasts for 7-10 days after thesurgery is completed, and it is during this time period in whichpotential suture breaks are more likely. With this in mind, and as thefollowing embodiments disclose, an adhesive, sealant, or medical fluiddelivery mechanism can be used in conjunction with the present suturingdevice to increase the short term strength of the stomach pouch byadhesively binding the opposed tissue. A method of deployment ofsealants or other medical fluid changes the stiffness properties of thetissue to improve the suture strength of the gastroplasty by adhesivelybinding the opposed tissue.

As such, and in accordance with a preferred embodiment of the presentinvention shown in FIG. 69, adhesive 3210 is used to improve short termstrength of the suture line 3213, that is, the line of tissue heldtogether via the suture 3212. A fluid deploying mechanism is utilized tolay down a line of fluid sealant or adhesive 3210 along the suture line3214 after the suture line 3214 is completed to improve holding strengthof the line. Either a thin layer adhesive or a foaming (void filling)adhesive or sealant 3210 can be used in conjunction with the suture3212.

In accordance with an alternate embodiment, and with reference to FIGS.70, 71 and 72, the suture 3312 is a hollow tube suture with periodicperforations 3314 along its length. Once the suture line 3313 isfinished, the suture 3312 would be pumped full of the sealant oradhesive 3314 allowing it to be distributed all along its lengthincreasing both the effective diameter of the suture, minimizing suturemigration as well as providing a complimentary adhesive bond of thetissue together in addition to the suture line 3313.

Referring to FIGS. 73 to 82, yet a further embodiment is disclosed. Aliquid polymer extrusion 3350 is used to form a sleeve 3352 around theinternal pouch 3353 formed in, for example, the stomach 3354. The entireinside of the small gastroplasty created pouch 3353 and some length ofthe intestines would be coated with the polymer/adhesive 3350. This notonly improves the strength of the pouch suture line, it also potentiallycreates some form of malabsorption compliment to the procedure thatimproves weight loss.

More particularly, and with reference to the various figures, a suctionand application device 3356 is first transorally inserted within thestomach 3354. A vacuum is then created drawing opposed tissue surfaces3358, 3360 together as shown in FIGS. 73 and 74. Thereafter, the liquidpolymer extrusion 3350 is applied to the opposed tissue surfaces 3358,3360 while the vacuum continues to be applied in a manner keeping thewalls 3358, 3360 of the stomach 3354 in apposition. Eventually, theliquid polymer extrusion 3350 will cure holding the apposed tissue walls3358, 3360 in apposition. Thereafter, and with reference to FIGS. 79 and80, the suction and application device 3356 in accordance with thepresent invention may be withdrawn and the internal profile of thestomach 3354 is reduced to a simple passageway extending therethroughwith a substantial portion of the stomach closed off from foodabsorption. Although the process described above does not employsutures, the pouch could certainly be formed with suturing of theopposed tissue with the subsequent application of adhesives as describedabove.

While the preferred embodiments have been shown and described, it willbe understood that there is no intent to limit the invention by suchdisclosure, but rather, is intended to cover all modifications andalternate constructions falling within the spirit and scope of theinvention.

The invention claimed is:
 1. A method for suture lacing, comprising: a.providing a suture with a needle attached thereto; b. inserting theneedle and suture into an organ through a passageway; c. throwing asingle stitch through a first tissue member in a proximal to distaldirection, throwing a single stitch through an opposed and spaced apartsecond tissue member in a proximal to distal direction; d. repeatingstep (c) at least once; e. throwing a final suture throw in either thefirst tissue member or the second tissue member and reversing thedirection of the final suture throw, the step of reversing includespositioning a reversing pin between the suture and either the firsttissue member or the second tissue member; f. bringing the first andsecond tissue members in contact by tensioning the suture, wherebysuture drag is minimized during the tensioning and even tissuecompression substantially achieved; and g. securing the suture.
 2. Themethod according to claim 1, wherein the suture includes first andsecond leads, and the step of securing includes knotting the first andsecond leads of the suture.
 3. The method according to claim 1, whereinthe suture includes first and second leads and the step of securingincludes anchoring at least one of the first and second leads of thesuture to tissue.
 4. The method according to claim 3, wherein the stepof securing includes anchoring both the first and second leads of thesuture to tissue.
 5. The method according to claim 1, wherein the stepof inserting includes insertion through a natural orifice of a patient.6. The method according to claim 5, wherein the step of insertingincludes insertion through an orifice from approximately 3 mm toapproximately 24 mm in diameter.
 7. The method according to claim 1,wherein the step of inserting includes insertion through a trocar. 8.The method according to claim 7, wherein the step of inserting includesinsertion through an orifice from approximately 3 mm to approximately 18mm in diameter.